Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency

NCT ID: NCT01651000

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-07-31

Brief Summary

This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated

Detailed Description

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CTAP101 Capsules administered for 26 weeks to treat SHPT in subjects ≥18 years of age with stage 3 or 4 CKD and vitamin D insufficiency. The study will be conducted at approximately 40 sites within the United States (US). Approximately 550 subjects will be screened to randomize approximately 210 eligible subjects, stratified by CKD stage (approximately 105 subjects in each stage) in a 2:1 ratio to receive either CTAP101 Capsules or matching placebo. An Interactive Voice Response System (IVRS) will provide study treatment group assignments using the computer-generated randomization code provided by the IVRS vendor. Subjects will receive an initial daily dose of 1 capsule (CTAP101 Capsules, 30 µg, or matching placebo) for the first 12 weeks. After l2 weeks (visit 8) and per pre-defined criteria, the dose may be increased in a blinded fashion by the IVRS with oversight by an independent medical monitor.

Conditions

Chronic Kidney Disease; Hyperparathyroidism, Secondary; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CTAP101 30 μg capsules

1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.

Group Type: ACTIVE_COMPARATOR

CTAP101 30 μg capsules

Intervention Type: DRUG

CTAP101 30 μg capsule taken daily at bedtime.

Sugar pill to CTAP101 30 μg capsules

Intervention Type: OTHER

Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

Sugar pill to CTAP101 30 μg capsule

1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.

Group Type: PLACEBO_COMPARATOR

Sugar pill to CTAP101 30 μg capsules

Intervention Type: OTHER

Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

Interventions

CTAP101 30 μg capsules

CTAP101 30 μg capsule taken daily at bedtime.

Intervention Type: DRUG

Sugar pill to CTAP101 30 μg capsules

Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

Intervention Type: OTHER

Other Intervention Names

Calcifediol; Placebo

Eligibility Criteria

Inclusion Criteria

1. Urinary albumin excretion ≤ 3000 mcg/mg of creatinine

2. Stage 3 or 4 CKD

3. Plasma iPTH: ≥ 85 pg/mL and < 500 pg/mL

4. Serum Ca: ≥ 8.4 mg/dL and < 9.8 mg/dL

5. Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL

6. Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and < 30 ng/mL.

7. Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2 months

Exclusion Criteria

1. History of kidney transplant or parathyroidectomy

2. Spot urine calcium:creatinine ratio > 0.2 (>200 mg/g Cr)

3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis

4. Currently on dialysis

5. Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per month) during the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OPKO IP Holdings II, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Melnick, MD

Role: STUDY_DIRECTOR

Opko Renal

Locations

OPKO Renal

Bannockburn, Illinois, United States

Countries

United States

Other Identifiers

CTAP101-CL-3001

Identifier Type: -

Identifier Source: org_study_id